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Submit preclinical data in animal and Phase I CT data: CDSCO Panel Tells IQVIA on Pembrolizumab study
New Delhi: After reviewing the Phase I/III clinical study protocol of the anti-cancer drug Pembrolizumab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined IQVIA RDS (India) to submit preclinical study data in animals, Phase-I complete study data including all pharmacokinetic and immunogenicity data.
This came after IQVIA RDS (India) presented phase I/III clinical study protocol no:BAT-3306-002-CR, Version:1.0, dated 19 Dec 2023.
Pembrolizumab is a type of targeted therapy drug called an immune checkpoint inhibitor (a type of immunotherapy). It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells
Pembrolizumab binds to the PD-1 receptor on T cells, preventing the PD-1 receptor from binding to its ligands, PD-L1 and PD-L2. This allows T cells to function normally and attack cancer cells.
At the recent SEC meeting for Oncology held on 9th October 2024, the expert panel reviewed the phase I/III clinical study protocol no:BAT-3306-002-CR, Version:1.0, dated 19 Dec 2023.
After detailed deliberation, the committee opined that the firm should submit preclinical study data in animals, and Phase-I complete study data including all pharmacokinetic and immunogenicity data for further review by the committee.
Also Read: CDSCO prioritizes transparency, digitizes more than 95% regulatory processes
Doctor of Pharmacy
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751